Cleared Traditional

K201040 - Bioflux Software II

K201040 is an FDA 510(k) clearance for Bioflux Software II, manufactured by Biotricity. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K201040 · Biotricity · Cardiovascular device
Download Printable Device Report (PDF)
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Jul 2020
Decision
119d
Days
Class 2
Risk

K201040 is an FDA 510(k) clearance for the Bioflux Software II. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Biotricity (Redwood City, US). The FDA issued a Cleared decision on July 29, 2020 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotricity devices

FDA 510(k) Submission Details - K201040

510(k) Number K201040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date July 29, 2020
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 78
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K201040.
Carnation Ambulatory Monitor (CAM)
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M5 Recorder
K202456 · Global Instrumentation, LLC · Dec 2020
Strados Remote Electronic Stethoscope Platform (RESP)
K201077 · Strados Labs · Dec 2020
Carnation Ambulatory Monitor
K200870 · Bardy Diagnostics, Inc. · May 2020
Carnation Ambulatory Monitor
K192556 · Bardy Diagnostics, Inc. · Oct 2019
Carnation Ambulatory Monitor
K191471 · Bardy Diagnostics, Inc. · Aug 2019